The coxo-femoral joint, commonly known as the hip, is a fundamental element of the human skeleton and must be in proper position in order for a person to have a harmonious walk and in order for a person to carry out normal physical activity both during childhood as well as during the whole life of the same. Because of its anatomical configuration and operation this joint must be considered one that is unique in the organism. It has two bony elements as follows:
1. A cup-shaped excavation known as the acetabulum which is designed to receive the second element described below. PA1 2. The upper end of the femur, which is almost spherical, is known as the femoral head. For the proper functioning of the joint and so as not to produce friction between the two elements during walking, the depth of the "cups" muse be such that the sphere of the head is fully lodged and totally covered by the upper part of the "cup", known as the "acetabular roof" PA1 1. Fredjka's cushion PA1 2. Von Rosen's splint; and PA1 3. Pavlik's harness
The injuries in this joint, presently known indistinctly as C.L.H. (Congenital Luxation of the Hip) or C.D.H. (Congenital Dysplasia of the Hip)" constitute a serious health problem worldwide, not only among children but also with disastrous repercussions in adults.
There are two main types of joint injury. The first or "type 1" joint injury is an injury wherein the head definitely leaves the cup-shaped receptor. This type of luxation greatly depends on customs and traditions of people, with greater incidence in some social ambiances as compared to others. Certain local customs contribute to the luxation which tend to place the baby's femur in an inadequate position which propitiates the exit of the head from the acetabulum or pelvic cavity. An example of such a custom can be seen in the way the baby is wrapped in certain communities such as the Guambiano communities in Colombia where the baby is wrapped in a position tending to put together both femurs which position often results in the exit of the femur head from its pelvic cavity The second or "type II" joint injury is an injury wherein the femoral head remains within the firm acetabulumn; but since the "cup" lacks the ideal depth, the acetabular roof cannot cover completely the head. Given that the femoral head is within its "cup" and the joint is stable, no, pathological sign is appreciated when conducting a clinical examination. Thus this second type of injury is typically an asymptomatic type of injury, often going without being noticed until adult age, when, because of weight increase and natural wear of the joint, the injury produces pain which can be incapacitating. X-rays nevertheless show that the cause is coxo-artrosis. The treatment of this ailment in adults is complicated and difficult, since it supposes the total replacement of the hip with prosthesis which prosthesis must be operated upon whenever they come out of adjustment which occurs at variable intervals. Before the end of a five year period after surgery, 54% of people under 30 years of age who were subject to a total hip replacement are again subject to surgery because of maladjustments of the prosthesis. Complications that occur during his delicate surgery, presumed to take place each year with more frequency, has forced the initiation of the use of an orthopedic-robot, already patented, in order to carry out the bony cuts and couplings with more precision than the human hand. And the much more serious complications which arise during a total hip replacement procedure has led NASA to design a micro-transmitter, also already patented, in order to investigate the causes of the lack of adjustment. Not considering the surgical expenses, and the often less than satisfactory results of such procedures, the incapacities caused by artosis, which affect the U.S. payroll, is estimated to reach a total of $13 million a year. For Colombia even though reliable data is not available, the damages are similar. Consequently many countries, like Italy, are looking for a surgical correction of the problem among children.
The definitive optimum solution consists in an early diagnosis of the coxo-femoral injury in babies and dealing with it in an efficient and safe way with very low costs and complications. Nevertheless even in developed countries like the United States, England, Sweden, Italy, etc., more than 50% of children with Type I injuries, which injuries are afterwards verified by accident, are not diagnosed during the checkup done when they are newborn.
Only during the last years has the conclusion been reached that the much more frequent and serious repercussions on adults, who otherwise were previously thought to be free of a hip injury or hip problems, are due to coxo, femoral injuries considered "minimal" or not discovered upon a physical examination during infancy. Such minimal coxo-femoral injuries are present in X-rays taken during infancy, but because of the minimal nature of the deviation and the lack of appreciation of the potential adult ramifications were not recognized by the treating physicians, which is understandable since no one knew or suspected that the minimal joint injury would afterwards be the cause of irretrievable decay of the hip (coxo-artrosis).
During infancy and at the baby level, this type of injury might be successfully treated by a "physiological" method, without any hospitalization, only using the participation of the baby's mother. Presently, nevertheless, none of the conventional methods used worldwide for the treatment of cases, even those with early diagnosis are exempt of producing the death of the femoral head (avascular necrosis). This complication is so serious that if it is total, causes such a sever joint deterioration that the child would have preferred never having the luxation diagnosed.
The sensible way of diagnosing the injury, placing in evidence the joint pathology in the newborn, is described in the book by the applicant of the present invention named "CONGENITAL DYSPLASIA OF THE HIP-LOGICAL CONDUCT," Dr. Nectar Daza Vasquez 1986, Bogota, which is hereby included as reference.
The mechanical devices in the prior art designed for physiological treatment of said congenital malformation have as a general purpose the forcing of the femoral head inside the hip acetabulum. Since the bone system of the newborn is more cartilaginous than bony, the location and permanence of the femoral head within the acetabulm turns out to be relatively easy and it consolidates within a few days.
Actually, several mechanical devices are known for treatment in the newborn of the coxo-femoral injury, also known as dysplasia or congenital luxation of the hip.
The main devices are:
In Fredjka's cushion, a rigid cushion is placed under the legs of the baby, so that they are separated and falling over ends of the cushion, while it is affixed to the baby's body by means of a breastplate hanging from the shoulders.
In Van Rosen's splint, a structure to be affixed to the baby's back is presented, while underneath appear clamps one for each leg, which keep the legs horizontally separated.
In Pavlik's harness, a harness component is affixed to the chest of the baby, while rigid straps, one for each leg, are laterally hung in order to separate the legs horizontally. In all three devices, the legs are horizontally spread so that the femoral head penetrates the acetabulum.
However, said devices have fixed dimensions which do not adapt well to the body of the baby during all of the treatment. Also given that the baby evolves quickly, all of the above devices tend to exert less separation between the legs of the infant, thus allowing a certain degree of undesirable movement between the femoral head and the acetabulum.